Multi-component frame for use in an orthopedic device

ABSTRACT

A multi-component frame includes a first component made from a rigid structural material and a second component connected to at least an end portion the first component. The first component is constructed from a metal or metal alloy, and the second component is constructed from a material different from the first component. The first and second components form at least part of a length of the multi-component frame.

FIELD OF THE DISCLOSURE

The disclosure relates to a frame for an orthopedic device, and morespecifically to a multi-component frame formed from layers or sectionsof different materials arranged in a predetermined configuration, andmeans for attaching features, such as straps, to a structure in anorthopedic device.

BACKGROUND

Orthopedic devices or braces comprise a broad range of structures anddevices used for supporting or stabilizing a joint when worn on the bodyof a user. Orthopedic braces may serve in either preventive or remedialroles. In the preventive role, the orthopedic brace can provideadditional support, stability, and protection to a healthy joint toprevent or minimize injury to the joint due to undue stress. In theremedial role, the orthopedic brace can support and strengthen a jointweakened due to injury or infirmity, and reinforce the vulnerable jointto prevent further injury, to correct or assist the infirmity, or tofacilitate healing of the joint.

A predominant orthopedic brace is a knee brace, which is used tostabilize the knee by preventing excessive movement of the knee orfacilitate the motion of the knee. Many knee braces comprise a frame andhave hinges on at least one of the lateral and medial sides of the kneejoint. Straps are used to secure the brace to the leg or knee. Aninjured knee can be fit with an “off-the-shelf” brace or with a“custom-fit” brace, with the selection of the brace depending on thesize and shape of an individual's leg. A clinician may further formeither type of braces by providing the frame with malleable materials tocustomize the frame to the user.

As shown in FIG. 1 , an exemplary knee brace 10 typically includes aframe that comprises at least one support member 12, 14. When there aremultiple support members 12, 14, the knee brace 10 may includerotational hinges 16 that assist and control the movement of the limb.Suitable straps 20 depend from strap attachments 22 and may maintain theknee brace 10 on the limb, and other features such as pads 18 mayrelieve the pressure of the knee brace 10 on the limb and surroundingareas.

Many knee braces reduce knee instability following an injury, counteractfatigue, and treat the impairment of the knee, particularly if the kneehas damaged ligaments. Braces may be recommended for walking, skiing,running, twisting, pivoting, or jumping activities. Besides providingincreased stability to the knee, knee braces may also decrease the riskof injuring the knee or leg or may assist the knee. One way ofprotecting the knee is by including attachments such as apatella-protector assembly which may be secured onto the knee brace andconfigured to operate to protect the patella from impact during physicalactivities.

To maximize its supportive, protective, and comfort-related aspects, itis desirable that a knee brace securely and precisely fit the leg of theuser. While custom-fit braces are made to intimately conform to theprecise geometry and dimensions of a leg of a user, it is typical forthe geometry and dimensions of the leg to change over time due to weightchange, muscle change, inflammation, medical conditions, or otherfactors, requiring even a custom-fit brace to accommodate manygeometries of the leg. As for off-the-shelf braces, these braces must beconfigurable to generally suit many leg geometries despite the geometryof a particular leg. There is a need for braces that accommodate auser's dynamic dimensions.

Existing braces further fail to account for the geometrical anddimensional variations between different parts of a leg, e.g., thedifference in shape between the calf and the shin. Certain areas of theleg require more accommodation from the brace than others, but mostbraces have only flat frame components and thus fail to address thisneed.

In recognizing the need for effective knee braces, various knee braceshave been introduced into the marketplace. Such knee braces, however,have generally comprised relatively heavy, bulky apparatuses that failto provide ventilation and to evenly distribute pressure from the braceon the leg of the user. Many contemporary braces are deficient becausethe braces are constructed in a manner that lacks or does notconsistently provide adjustment features for forming a firm,comfortable, and secure interface between the unique and dynamicdimensions of the leg and knee of the user and the brace. Because ofthese drawbacks, many knee braces detract from the user's endeavor.

For example, some strap supports may be deficient because they add tothe brace's bulk by jutting out from the frame with a rigid strapsupport structure. These features may cause discomfort for a user,increasing the size, profile, and weight of the brace, increasing thecost to a user and making the brace cumbersome to use because of thebrace's larger size. Such straps may further increase the risk of damageto the brace and discomfort for a user if, for example, the outwardlyjutting straps catch on objects or clothing.

Braces may need to incorporate auxiliary structures such as sensors,padding, structural support, or aesthetic features into the frame.Existing braces, which utilize flat metal structures, do not have aconvenient disposition for such auxiliary structures and thus theauxiliary structures must attach or append to the brace, often inuncomfortable, unsightly, and maintenance-intensive ways. This furtherincreases the bulk of the brace.

The features of the present disclosure are provided in recognition ofthe need for orthopedic braces and components in both custom-fit andoff-the-shelf braces to achieve superior functional performancecharacteristics while being comfortable to the user when worn andadapting to the user's dynamic dimensions. This recognition is realizedwith the embodiments described in the disclosure.

SUMMARY

The multi-component frame of the disclosure addresses the problem ofexisting frames being bulky, which hinders patient compliance and use.The multi-component frame of the disclosure increases strength overknown frame systems and leads to a streamlined arrangement with improvedconcealment of padding, cushioning, and skin-facing layers. These layersare located generally within a concavity of the multi-component frame.These improved features contribute to the multi-component frame beingmore lightweight, comfortable, and low-profile over known deviceswithout sacrificing desired strength.

As an alternative or besides multi-component layers, the multi-componentframe may comprise multi-component segments juxtaposed or abutting oneanother along a length or a course of a frame assembly. For example, aframe assembly may be defined as having a continuous length between endpoints, such as at hinges, although it is generally contoured to a limbupon which it is secured. The frame assembly comprising amulti-component frame has at least two segments juxtaposed, abutting oroverlapping one another at their end portions along the length and maycorrespond to different sides of the limb, or be adapted to differentdegrees of stress the segments may undergo at a particular location ofthe limb during activity and inactivity.

By “multi-component,” it should describe the multi-component frame ascomprising layers or structural features formed from different materialsused for strengthening, concealing, contouring, padding, and otherintended benefits, particularly in the art of orthopedic devices. Themulti-component frame includes at least two layers or segments ofdifferent materials, adjacent to one another along at least a portion oftheir length or end portions in predetermined locations and providingcomplementary structural benefits.

The multi-component frame may start with a first or base component of ametal frame upon which supplemental components may be attached. Whilethe metal frame may be sufficiently strong to withstand forces exertedby or imposed upon a user during use, the strength may be furtherenhanced by adding structural components, such as fiber-reinforcedlayers or inserts attached to the metal frame. The metal frame may beprovided with padding or cushioning layers adapted for being adjacent tothe skin and anatomy of the user.

The metal frame may be provided with a curved or concave profile, withthe concavity located to face the user, and in which the additionalcomponents are received. The curved profile of the metal frame offers byitself enhanced mechanical strength over a conventional flat metalframe, and can easily be enhanced with additional layers of structuralmaterials located within a cavity formed by the curved or concaveprofile.

In an exemplary embodiment, the entire or near entire metal frame ishollow or has a concave cross-section. An advantage of a metal frame isthat it can be malleable. While orthopedic devices may be made out ofcarbon fiber, plastic or other suitable structural materials where anentire frame is hollow or concave, these frames are not malleable andthus are not adaptable to a user's unique and dynamic dimensions andneeds. Carbon fiber is brittle, and making a thin low-profile carbonfiber frame is difficult and potentially hazardous to the user. Theframe often is thick in structure, and may deleteriously add undesirableweight.

Most orthopedic devices having a metal frame defined with a flatcross-section because it is obtained with little difficulty during themanufacturing process. Some devices are molded from carbon fiber anddefine a frame with a hollow oval cross-section. However, such devicesmust be sufficiently bulky to balance the drawbacks of using carbonfiber, such as brittleness. There are other devices having frames moldedout of metal, carbon fiber or plastic with oval or partial ovalcross-sections, yet such configurations sacrifice either a desiredstrength, malleability, or weight.

A metal frame with a continuous concave cross-section provides both highstrength and reduced weight and profile, and is malleable and notbrittle. The expression “malleable” has its ordinary meaning of beinghammered, pressed, or otherwise formed permanently out of shape withoutbreaking or cracking. Traditional flat knee brace frames are made byrolling a flat piece of metal around a mandrel to create a shape to fitthe leg. Such an arrangement or process cannot be done with a concavecross-section because the metal would buckle, crease, and fold onitself. According to this embodiment with a metal frame, a solution isprovided which solves these design and manufacturing challenges andcreates a unique and more structurally advanced metal knee brace framewith a continuous concave cross section throughout the frame.

The curved or concave profile of the metal frame enables inserts intothe profile that can yield and adapt to the shape to the user. Forexample, most prior art orthopedic devices have flat surfaces thatmerely approximate to a user's anatomy. While users with greater sizeand fleshy regions are less affected, smaller users' anatomies do notadapt well to or fill out the space defined by flat surfaces, renderingthe assistance from the orthopedic device suboptimally effective and/oruncomfortable.

The multi-component frame can have inserts that have a curved surfacearranged adjacent to the user's anatomy and which conforms better to theuser's anatomy. This arrangement is useful to women and children who mayhave smaller calves. The adjacent curved structure of themulti-component frame can contour to the curvature of the user's calfrather than merely offering a flat surface, providing a better and morecomfortable fit between user and brace.

It is found that some preferred metals and alloys thereof may beexpensive to form in ways described above to form an entirety of a frameassembly. According to another embodiment, a frame assembly may comprisesegments along a continuous length thereof, generally defined betweentwo endpoints such as at a hinge or a pair of hinges, that are formedfrom different materials. For example, a first segment may couple to orform part of a first hinge and be constructed from malleable steel oraluminum. Such first segment may be long or shortened by being receivedby a second segment that may formed from a strong and light structuralmaterial but of a material not generally malleable in service, such as aresin-impregnated carbon fiber or fiber-reinforced polymeric material.The second segment attaches to a first end portion of the first segment,and the pair of first and second segments may correspond to a lateral ormedial side of a user's leg with a knee brace. The combined structure ofthe first and second segments may be continuous without interruption.

A third segment of a metal or alloy thereof may have a first end portionsecuring to the second end portion of the second segment, and may beformed from a different material than the second segment. For example,the third segment may generally correspond to a cuff part of a kneebrace generally perpendicular or transverse to the femur or tibia, andmay require construction from a malleable yet strong material, such astitanium. A second end of the third segment may secure to a second endof a fourth segment generally opposite to the second segment, along alateral or medial side of the leg. The fourth segment has a first endsecuring to a fifth segment coupling to or forming part of a secondhinge, so each the fourth and fifth segments may correspond respectivelyin material selection as the second and first segments, respectively.From the preceding embodiment, the length of the frame assemblycomprises the first, second, third, fourth and fifth segments of theframe assembly, generally end-to-end to form the length of the frameassembly.

To accommodate and attach features such as straps to the orthopedicdevice, means for attaching the features may secure to the frame andgenerally correspond in strength to the strength of the frame assembly.According to an embodiment, a strap attachment or D-ring is provided ina streamlined manner to mitigate or minimize a strap attachmentprotruding from the frame without compromising the strength of the strapattachment. Because of constructing the strap attachment, the strengthis enhanced over conventional strap attachments in that the embodimentcomprises a cable pivotally secured to the frame. The strap attachmentmay include a coaxially arranged tube along at least a segment of alength of the cable so the tube may rotate about the cable toaccommodate movement of a strap tethered thereto. The cable may beconstructed from an elongate element such as a wire or braided cable,and both the cable and the tube may be formed from metal.

These and other features, aspects, and advantages of the disclosure willbecome better understood regarding the following description, appendedclaims, and accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a prior art knee brace.

FIG. 2 is a perspective view of an embodiment of a multi-componentframe.

FIG. 3 is a detail view of a cross-section taken along line in FIG. 2 .

FIG. 4 is an extended view of the cross-section taken along line in FIG.2 .

FIG. 5 is a perspective view of a variation of the embodiment of FIG. 2.

FIG. 6 is a perspective view of a segment of another embodiment of amulti-component frame.

FIG. 7 is a perspective view of an insert in the multi-component frameof FIG. 6 .

FIG. 8 is a perspective view of a variation of the segment of FIG. 6 .

FIG. 9 is a perspective view of a corner segment of a multi-componentframe.

FIG. 10A is a front elevational view of a knee brace having amulti-component frame.

FIG. 10B is a side elevational view of the knee brace of FIG. 10A.

FIG. 11 is a partial schematic sectional view of a lower frame assemblyof the multi-component frame of FIG. 10A.

FIG. 12 is a rear partial schematic view of a section of the lower frameassembly in FIG. 11 .

FIG. 13 is a partial front view of a strut section of the lower frameassembly in FIG. 11 .

FIG. 14 is a partial rear view of the strut in FIG. 11 including strapsand D-rings.

FIG. 15 is a plan view of the D-ring in FIG. 14 .

DETAILED DESCRIPTION OF VARIOUS EMBODIMENTS

A better understanding of different embodiments of the disclosure may behad from the following description read with the drawings in which likereference characters refer to like elements.

While the disclosure is susceptible to various modifications andalternative constructions, certain illustrative embodiments are shown inthe drawings and are described below. It should be understood, however,there is no intention to limit the disclosure to the specificembodiments disclosed, but on the contrary, the intention is to coverall modifications, alternative constructions, combinations, andequivalents falling within the spirit and scope of the disclosure.

Numerical qualifiers (i.e., first, second, etc.) are used in thefollowing discussion merely for explanatory purposes and are notintended to limit their location or the amount of segments or componentsof the embodiments.

According to FIGS. 2 and 3 , a multi-component frame 100 has a basecomponent 102 comprising edge portions 120, 122 having a different shapethan a shape of a main body portion 119. The main body portion 119defines a concave cross-section 124 and forms a concave portion, orrecess 125 adapted to receive additional layers including, but notlimited to, a reinforcing layer 104 and padding layer 106.

By “continuous,” it is meant that the edge portions 120, 122 and themain body portion 119 can be formed from a single piece withoutinterruptions or sections adhered thereto. The base component 102 maycomprise an elongate structure formed according to a predetermined shapeso the predetermined shape is formed from the elongate structure in itsentirety.

The base component 102 may be made from a rigid structural material, anddefines first and second sides 103, 105 and the concave cross-section124. The base component 102 is constructed from a metal such as a metalalloy including titanium or aluminum. An insert or layer 104 may extendalong the first side 103 of the base component 102 and may beconstructed from a different material than the base component 102. Theinsert or layer 104 may be arranged as a reinforcement layer 104. Thedifference in materials may be provided, so the multi-component frame100 balances and optimizes the characteristics and benefits of thematerials of the base component 102 and the reinforcement layer 104.

The base component 102 may be uniformly formed as having the samecross-sectional profile along lengths of the base component 102, incontrast to corner sections. The base component 102 may likewise have auniform thickness along its length or may have a variable thicknessdepending on areas requiring enhanced strength (i.e., corner sections).The base component 102 may define definitive peripheral edges to themulti-component frame by the edge portions or may be adapted with lips,flanges, or other structural features for interlocking with othercomponents, as described in embodiments herein.

The reinforcement layer 104 is not limited to a single layer, but rathermay comprise multiple or different layers from different materialsdepending on their proximity to the base component 102 and according totheir specific characteristics. For example, the reinforcement layer 104may be constructed from a resin-impregnated material including areinforcement fiber selected from the group of carbon, glass, andKevlar. This arrangement (the shape and size of the base component 102and in some embodiments, the provision of a reinforcement layer 104)advantageously allows the strength, weight, and bulk of an orthopedicdevice comprising the multi-component frame 100 to be optimized, so theweight and profile of the base component 102 may be minimized withoutsacrificing needed strength. This may beneficially minimize the costs ofmaterials and constructions and improving the comfort for a user (e.g.by reducing the weight of the device).

The first side 103 of the base component 102 may define flanged edgeportions 120, 122. The concave cross-section 124 includes a concaveportion 125 extending between the flanged edge portions 120, 122. Fromthe contour of the flanged edged portions 120, 122 and the concavecross-section 124, a three-dimensional shape (as opposed to the flatshape and profile of existing frames) is achieved, as the concavecross-section 124 protrudes outwardly away from the flanged edgeportions 120, 122, and hence the user's body as the second side 105defines the outermost surface or section of multi-component frame 100relative to a user.

Referring further to FIGS. 2 and 3 , a thickness T1 separates the firstand second sides 103, 105, and is generally uniform along a length ofthe base component 102. The second side 105 of the base component 102follows a shape of the first side 103 and extends parallel therewithalong a length of the base component 102. The reinforcement layer 104extends at least along the concave portion 125, and parallel with thelength of the base component 102. This arrangement generally results ina uniform shape of the base component 102 at different locations.

Referring again to FIG. 2 , the base component 102 may include a firstsegment 128 extending in a first direction and a second segment 130generally parallel with the first segment 128, and a curved segment 132extending between the first and second segments 128, 130, as seen alsoin FIG. 1 . Unlike the prior art frame in FIG. 1 which is substantiallyflat, the concave cross-section 124 of the multi-component frame 100 inFIG. 2 extends along and through the first, second, and curved segments128, 130, 132. The curved segment 132 extends generally perpendicular tothe first direction, and the reinforcement layer 104 extendscontinuously along the base component 102 from the first and secondsegments 128, 130. The first segment 128 defines a corner area 126 atwhich the curved segment 132 extends away from the first segment 128.

The concave cross-section 124 may be provided along an entirety of thelength of the base component 102 extending across the first, second, andcurved segments 128, 130, 132 to extend continuously withoutinterruption in an elongate single piece, simplifying use and minimizingproduction and maintenance costs and issues. In embodiments, the concavecross-section 124 may be provided in discrete locations along the basecomponent 102, such as, for example, along elongate portions of at leastone of the first and second segments 128, 130.

The base component 102 may define an opening 136 through which isexposed a surface of the reinforcement layer 104, or another layer, suchas the padding layer 106 if arranged adjacent the first side 103 of thebase component 102. The opening 136 may reduce material of the basecomponent 102, particularly when less strength and support is requiredalong certain locations of the base component 102, thereby reducingbulk, weight, and cost of the multi-component frame 100. The opening 136may have a tapering section 134 at an end portion thereof to transitionback to portions of the base component 102 without the opening 136. Thebase component 102 may form at least one recess or aperture 112 along orthrough the second side 105, respectively, to provide ornamentalfeatures, reduced weight, added flexibility, or enhanced breathability.

In alternative embodiments, in place of the opening 136, an indentationmay be defined by an outside surface of the base component 102 in whichan external reinforcement layer may be disposed for added strength.While portions of the multi-component frame 100 are uniform inthickness, additional layers or thicknesses of reinforcement materialmay be provided in any section where added strength and rigidity aredesired.

As shown in FIG. 3 , the reinforcement layer 104 has a first sideadjacent the first side 103 of the base component 102. When providedwith the reinforcement layer 104, the padding layer 106 extends alongthe reinforcement layer 104 within at least the concave cross-section124. The thickness T1 of base component 102 may be less than a thicknessT2 of the reinforcement layer 104. The reinforcement layer 104 may beconfined within and may fill the concave portion 125. The reinforcementlayer 104 may have tapered ends 114 reaching to and being at or above atthe flanged edge portions 120, 122.

The arrangement of the multi-component frame 100 in FIGS. 2 and 3advantageously provides increased mechanical strength, owing to thematerial and especially the concave profile of the base component 102,while also advantageously providing a concave portion 125 thatfacilitates the disposition of an additional reinforcement layer 104 anda padding layer 106 (among other possible auxiliary structures), andprovides a curvature that facilitates greater conformity of themulti-component frame 100 to a user's individual dimensions, bothlongitudinally and radially. The curvature overcomes the disadvantagesof flat frame elements in existing braces by providing a concave shapeand additional padding that better mimic the dynamic dimensions of auser's leg while minimizing cost, weight, and bulk.

This is especially advantageous for users, such as some women andchildren, for whom existing flat frames are not well-suited, as theframes may not closely and comfortably hug portions of their anatomy,such as at the calf. Children especially stand to benefit from amulti-component frame 100 that is more easily adaptable to their smallerand rapidly changing frames and dimensions, as many doctors andclinicians prefer treating the legs of injured children throughorthopedic braces to operating on them, yet existing orthopedic bracesfail to account for children's needs.

Turning to FIG. 4 , a strap attachment 110 is pivotally attached to thebase component 102 and supports a strap 108. The base component 102 mayform a recess 118 adapted for receiving the strap attachment 110. Thestrap attachment 110 comprises a pivotally attached cable 115 havingfirst and second ends 117, 119 pivotally attached to the base component102. The cable 115 may be formed from an alloy or other suitable metal,polymer, or composite material. A roller 116 is secured to the cable 115over which the strap 108 secures, and prevents binding of or otherinterferences with the strap 108.

The configuration of the strap attachment 110 in the recess 118advantageously reduces bulk and complication of a brace including themulti-component frame 100, as the strap attachment 110 may protrude lessoutwardly from the base component 102. This feature, combined with usinga pivotally attached cable 115 to flexibly secure the strap 108, reducesboth the size of the brace and the likelihood of discomfort while stillproviding needed strength.

FIG. 4 exemplifies how the multi-component frame 100 may only comprisethe base component 102 and the padding layer 106. The padding layer 106extends into the concave cross-section 124 having a thickness T3 greaterthan the thickness T1 of the base component 102. The padding layer 106may have edge portions 134 extending laterally beyond the side portionsof the base component 102 and/or toward the user beyond the basecomponent 102. By arranging the padding layer 106 within the concaveportion 125 defined by the concave cross-section 124, the size andprofile of the multi-component frame 100 may be reduced withoutcompromising comfort for a user, as the concave portion allows for acomfortable amount of padding 106 to be provided within the concavity125 of the base component 102 but without jutting outward therefromtowards a user and thereby increasing a profile of the brace. Padding106 that can be partially or wholly accommodated within the concavity ofthe base component 102 is greater (e.g., being thicker and morecomfortable) than padding normally and feasibly appended to flat framecomponents in existing braces.

FIG. 5 shows a variation of the strap attachment 110 of FIG. 4 , with astrap attachment 140 secured along a segment 144 of the multi-componentframe 141. In this variation, the strap attachment 140 includes a rigidbar 142 pivotally attached to the segment 144 within a recess 146 formedby the multi-component frame 141. The rigid bar 142 may be formed from astructural material, and may have a geometry and material strength toprevent yielding of a strap 108 looped thereabout and tensionedtherefrom. The recess 146 may have a profile to accommodate a shape of astrap portion, head, or segment. The recess 146 may also have atransitional depth 147, with greater depth at where the rigid bar 142secures to the multi-component frame 141. The transitional depth 147 hasthe added benefit of helping to guide the strap 108 in a usefuldirection and prevent migration over the user.

The rigid bar 142 advantageously provides sufficient strength to anchorthe strap 108 on the user without jutting outwardly by an inconvenientamount. This minimizes the profile of the multi-component frame 141 andis enabled by the recess 146.

A peripheral edge of the recess 146 may be recessed to form a flange 148to ease the transition of the multi-component frame 141 against theuser, and enable smooth rollover of the strap 108 over the peripheraledge of the multi-component frame 141 to better conform to the body ofthe user.

FIG. 6 illustrates another embodiment of a multi-component frame 200.The multi-component frame 200 has a base component 202 forming a concavecross-section 203 in and/or to which an insert 204 is provided andinterlocks with ledges or flanged arrangements 218 formed by the basecomponent 202. The base component 202 may be made from a structuralmaterial such as steel, aluminum, titanium, or other suitable metals andalloys, or fiber-reinforced composite, whereas the insert 204 may beformed from a polymeric material such as a thermoplastic elastomer.

A liner layer 206 may be a fabric layer located along a surface of theinsert 204, and intended to be adjacent the user. The liner layer 206may provide cushioning, reduce migration, and improve comfort to theuser. The liner layer 206 may be breathable, and have frictionalproperties. The liner may facilitate breathability by definingstructures that promote airflow, such as heat and fluid transfer, whilestill cushioning the user's limb. The liner layer 206 may be removablefor customization, replacement, and/or cleaning. For example, the linerlayer may be arranged with a surface as described in U.S. Pat. No.8,425,441, granted on Apr. 23, 2013, and incorporated herein byreference.

As shown in FIGS. 6 and 7 , the insert 204 may form a structure 208adapted to accommodate the user's anatomy with sufficient rigidity whileyielding in part to the user's anatomy and movement. In an exemplaryembodiment, the structure 208 forms an open-grid formation along a firstside of the structure 208 that corresponds to the concavity of the bracecomponent 202. The open-grid formation forms first and second sets ofrows 214, 216 with voids 220 located therebetween. The structure 208 maydefine a second surface 212 that may be continuously closed and alongwhich the liner layer 206 secures.

The insert 204 is interlocked with an edge configuration 209 of the basecomponent 202, whereby the insert 204 has an edge profile 210 thatextends over the edge configuration 209. The edge profile 210 extends toboth sides 211, 213 of the insert 204, and the second surface 212extends between the sides 211, 213. The edge configuration 209 maydefine at least one ledge or flanged arrangement 218 depending fromopposed sides of the base component 202, and extending into acorresponding opening 222 of the insert 204. The material difference ofthe insert 204 and the base component 202 provides a softer and morecomfortable edge over the more rigid material of the base component 202.

The edge profile 210 reduces irritation caused by substantially hard orsharp edges of the base component 202 and allows the base component 202to at least partially conform to the anatomy of the user by the edgeprofile 210. The body of the insert 204 with the structure 208 providesa compliant interface between the edge profile 210 and the basecomponent 202 and serves as a platform for the inner layer 206.

FIG. 8 exemplifies another frame segment 228 for a multi-component frameaccording to the disclosure and including an integrated strap retainer231. By “integrated,” it should mean that the integrated strap retainer231 may be formed by the base component 202, in both structure andmaterial. The integrated strap retainer 231 is continuous because it isformed by the base component 202. For example, the integrated strapretainer 231 forms a recess 232 within an exterior surface 233 of thebase component 202 over which a bar 236 extends from opposed sides ofthe recess 232 continuously with the material of the base component 202.The bar 236 possesses the strength of the base component 202, ensuring asecure attachment for a strap with minimized maintenance and assemblyissues. The bar 236 may be formed from the material of the basecomponent 202, or may be welded onto the base component 202 andsuspended over the recess 232.

The bar 236 may not extend outwardly beyond a periphery of the framesegment 228 and offers a low-profile, sleek, and intuitive integratedstrap retainer 231 without the necessity of additional components beyondthe mere body and structure of the frame segment 228. The recess 232 hasan outlet 234 proximate the edge 229 of the frame segment 228 thattransitions or slopes to the edge 229 and over an edge profile of aninsert. In this manner, a strap 230 can be secured to and extendoutwardly from the frame element 228 without significantly protrudingeither upwardly or laterally beyond the periphery of the frame segment228, without compromising structural strength or convenience of thestrap, frame, or brace.

FIG. 9 illustrates a variation of the integrated strap retainer 240located at a corner 238 of a frame segment 237. The integrated manner ofthe integrated strap retainer 240 in FIG. 9 , or the integrated strapretainer 231 in FIG. 8 , has the advantage of customizing the locationof the integrated strap retainers 231, 240 along locations of framesegments without the necessity of additional components, and can limitthe extent by which straps extend from the frame segments. The recess232 comprises a transition portion 242 extending from an interiorportion of the exterior surface 233 of the base component 202 to an edgeportion 244. The transition portion 242 facilitates a sleek,aesthetically pleasing, and intuitive functionality of the integratedstrap retainer 240 by visually and tactilely guiding a user or clinicianto the bar 236.

According to another embodiment in FIGS. 10A-15 , an orthopedic device300 has first or upper and second or lower frame assemblies 301, 303.Each of the upper and lower frame assemblies 301, 303 comprises segmentsalong a continuous length, L1, L2, respectively thereof, generallydefined between two endpoints such as at a hinge or a pair of hinges308, 309. The endpoints are not limited to hinges, and may be simplywhereat a corresponding frame assembly terminates. The frame segments inand defining the continuous length L1, L2 of each of the first or upperand second or lower frame assemblies 301. 303 are formed from at leasttwo materials.

Using the second or lower frame assembly 303 for example, a firstsegment 320 may couple to or form part of a first hinge 308 and beconstructed from steel, aluminum or other suitable material for formingpart of the first hinge 308. For example, the first segment 320 is ahinge element or strut. While in FIG. 11 the first segment 320 defines ahinge head 344, such first segment 320 is not limited to such structure.The first segment 320 may be long or shortened by being received by asecond segment 312 that may be formed from a strong and light structuralmaterial but of a material not generally malleable in service, such as aresin impregnated carbon fiber or fiber-reinforced polymeric material.The second segment 312 may be an elongate strut, generally parallel withthe leg. The second segment 312 attaches to a first end portion of thefirst segment 320, and the pair of first and second segments 320, 312may correspond to a lateral or medial side of a user's leg with a kneebrace. The combined structure of the first and second segments 312, 320may be continuous without interruption.

A third segment 310, such as being formed from a metal or alloy, mayhave a first end portion securing to the second end portion of thesecond segment 312, and may be formed from a different material relativeto the second segment 312. For example, the third segment 310 maygenerally correspond to a cuff part of a knee brace generallyperpendicular or transverse to a femur or tibia, and may requireconstruction from a malleable yet strong material, such as titanium. Thestrength of the third segment 310 may be enhanced by having athree-dimensional shape in contrast to a flat configuration, and may becontoured as in preceding embodiments. By limiting the length of thethird segment 310, the cost of using an expensive material such astitanium may be minimized and located in a focused manner to where itmay be most required, while using less expensive materials, such asmaterials forming the first and second segments which require lessstrength or customizability.

A second end of the third segment 310 may secure to a second end of afourth segment 314 generally opposite to the second segment 312,arranged along an opposed lateral or medial side of the leg. The fourthsegment 314 has a first end securing to fifth segment 322 coupling tothe second hinge 309, so each the fourth and fifth segments 314, 322 maycorrespond respectively in material selection as the second and firstsegments 312, 320, respectively. From the preceding embodiment, thelength of the frame assembly comprises the first, second, third, fourthand fifth segments 320, 312, 310, 314, 322 of the second or lower frameassembly 303, generally connected end-to-end to form the length L2 ofthe second or lower frame assembly 303.

By “being connected end-to-end,” it is indicated that the segments areat least connected to one another at their ends, but embraces thesegments overlapping one another and extending along one anothersegment's individual length, such as having overlapping portions inFIGS. 12 and 13 , or a slot connection in FIG. 14 . The segments may befastened to one another, as exemplified by fasteners in FIGS. 10A and10B, and FIG. 12 to secure to one another as with fasteners 336, 338.Alternative ways for securing segments may include adhesives or otherbonding techniques and means, and the ways for securing the segments maybe permanent or removable.

The first or upper frame assembly 301 similarly includes a first segment316, a second segment 304, a third segment 302, a fourth segment 306 anda fifth segment 318 corresponding generally to constructing the secondor lower frame assembly 303. While the depicted embodiment showssimilarity in construction of the first or upper frame assembly 301 andthe second or lower frame assembly 303, embodiments are not limited tosuch similarity. For example, either of the first or upper frameassembly 301 and the second or lower frame assembly 303 may have adifferent number of segments or may have only a sole segment.

The multi-component orthopedic device of FIGS. 10A and 10B isadvantageous over known orthopedic devices. Unlike prior art braces thatemploy a same material throughout the length of the frame of theorthopedic device. While in such prior art braces providing stiff strutsmay be expensive or heavy, they lack means for selectively balancingstrength and comfort. Rather, one of strength and comfort is oftencompromised to yield one quality more than the other.

It has been found that when there is a stiff strut, as in the embodimentof FIGS. 10A and 10B, the second and fourth segments or struts made froma material such as resin impregnated fiber or similar material, and thethird segment or cuff may be made to be more flexible due to thematerial selection and/or geometry, while still maintaining the strengthof the orthopedic device. A more flexible cuff, at least relative to thestrut, yields a more comfortable knee brace, without compromisingstrength of the orthopedic device The orthopedic device offers the samelevel of protection but does so in balancing strength and comfort byselecting appropriate materials and/or geometries for different segmentsof the orthopedic device, which cannot be achieved when a singlematerial frame is employed.

In the aforementioned embodiments, when the first, second and thirdsegments are constructed of different materials for their intendedpurpose and function (i.e., stiffness for the strut or second segmentand flexibility for the cuff or third segment), if a “malleable” or“adjustable” brace is desired, at least the gear extending to the hingeand the cuff should be malleable. Normally offering only one of the gearand cuff as being malleable cannot qualify as a malleable brace. Byinterposing a stiff strut between the first segment and third segment,each preferably having different material properties and being ofstiffness lower than the strut, the orthopedic device can qualify as amalleable brace while offering the aforementioned improved stiffnessprovided by a resin impregnated fiber or similar material strut.

While the segments are described as being constructed from differentmaterials, different segments may be adapted geometrically to havingdifferent properties, as compared to a frame having a single-materialconstruction and generally consistently sized and configured segments.For example, the second segment may have strengthening means, such asribs or a three-dimensional or arcuate cross-section that makes thesegment stronger over other segments if maintained of the same materialand generally same dimensions and configuration without thestrengthening means. The third segment may be sized and configureddifferent from an adjacent segment making it distinctly more flexiblethan the second segment. The third segment may still be sized andconfigured with strengthening means, however the second segment or strutmay be stiffer.

FIG. 11 exemplifies an outer section of the lower frame assemblyincluding the fifth segment 322 defined as a hinge element. The fifthsegment 322 includes an extension 342 forming a second end portion andis received by a slot 368 defined by at a first end portion 367 of afourth segment 314. The fifth segment 322 forms a hinge head 344 forminga first end portion and is adapted to mesh with a corresponding hingehead of the upper frame assembly (not shown). The fifth segment 322 maybe constructed from a variety of suitable materials for a hingeassembly.

As exemplified by FIG. 12 , the fourth segment 314 is generally elongatefrom the first end portion 367 to a second end portion 369 securing to afirst end 371 of the third segment 310. The fasteners 338 a, 338 b maybe defined as posts 354 a, 354 b connecting to a side of the thirdsegment 310 and extending through apertures 352 a, 352 b configured anddimensioned for receiving the posts 354 a, 354 b. The posts 354 a, 354 bmay be formed by or secured to the third segment 310. For example, thefasteners 338 a, 338 b may be accessible from an outside of the lowerframe assembly, as in FIGS. 10A and 10B, or may only secure to an insideof the lower frame assembly 303.

FIG. 13 shows how the first end 371 of the third segment 310 overlaps alanding 362 formed by the second end 369 of the fourth segment 314. Thelanding 362 may be a thinned section relative to a nominal thickness 358of the fourth segment 314.

FIGS. 11 and 12 shows how the fourth segment 314 has a peripheral edge348 colinear and continuous with a peripheral edge 349 of the thirdsegment 310. Both the first or upper frame assembly and the second orlower frame assembly each include liners 332, 334 extending along aninner surface and over peripheral edges. FIG. 11 illustrates how aperipheral edge of a liner 350 may extend over the coextensiveperipheral edges 348, 349 as in preceding embodiments. Likewise, thethird segment 310 may have openings 346 or be three-dimensionally formedas in preceding embodiments.

FIG. 14 illustrates an inner side of the fourth segment 314 with theliner removed. To accommodate and attach features to the orthopedicdevice, such as straps 324, 326, 328 a, 238 b, 330 a, 330 b, means forattaching features may secure to the frame and generally correspond instrength to the strength of the frame assembly.

According to an embodiment, a strap attachment or D-ring 340 is providedin a streamlined manner to mitigate protruding from the frame, such asat the fourth segment 314, without compromising the strength of thestrap attachment. Because of constructing the strap attachment, thestrength is enhanced over conventional strap attachments in that theembodiment comprises a cable 372 pivotally secured to the fourth segment314. The strap attachment 340 includes a coaxially arranged tube 374along at least a segment of a length of the cable 372 so the tube 374may rotate about the cable 372 to accommodate movement of a straptethered thereto.

Ends of the cable 372 may be secured to one another by a connector 376so the cable 372 can be a continuous loop. The cable 372 may be formedfrom an elongate element such as a wire or a braided cable, and may beformed from metal or polymeric material such as nylon. The tube 374 maybe formed from metal or a polymeric material, and may have radial endportions 375 to retain and reinforce a strap. The cable may be replacedwith a tubular member having a continuous structure formed or shaped asa loop to accommodate a tube or may be provided with or without suchtube.

The fourth segment 314 may have a cavity 356 to accommodate the strapattachment 340 which may comprise individual strap attachments 340 a,340 b, and 340 c. For example, the cavity 356 has a biasing form 370 toretain strap attachments such as the cable 372. The fourth segment 314preferably includes apertures 364 through which the strap attachment 340extends, and may be provided to retain the cable 372 in positionrelative to the fourth segment 314 or enlarged to allow for pivotingrelative to the fourth segment 314. The tube 374 is adapted to extendoutwardly relative to a periphery 371 of the fourth segment 314. Theperiphery 371 may include recesses to maintain the strap attachment 340close to the fourth segment 314 and contribute to a streamlinedconfiguration.

The strap attachment 340 with the cable 372 and tube 374 offers astronger strap attachment over conventional D-rings, particularly thoseconstructed from a simple metal ring or a plastic D-ring. As the cable372 and tube 374 may be constructed from metal, the strap attachment 340also enables smaller and thinner components to retain a strap. The strapattachment 340 can be closely secured to the frame so at to closelyapproximate a periphery of the frame, as shown in FIGS. 10A and 10B andFIGS. 12 and 14 .

These and other embodiments of the present disclosure overcome thedeficiencies of existing frames for braces by providing amulti-component frame that reduces bulk and weight without sacrificingneeded strength and provides adjustability for a user's specificdimensions. The advantageous three-dimensional configuration of themulti-component frame (as opposed to the flat configuration of frames inexisting braces), with depending edge portions and a concave portion,provides both mechanical strength and a recess wherein additionalsupport material, auxiliary structures, and/or padding may be discreetlyand conveniently disposed.

While the foregoing embodiments have been described and shown, it isunderstood that alternatives and modifications of these embodiments,such as those suggested by others, may be made to fall within the scopeof the disclosure.

1. A frame in an orthopedic device, comprising: a first component madefrom a structural metal material, the first component defining first andsecond sides, the first and second sides being coextensive and parallelso as to form a concave cross-section bounded by first and secondflanged edge portions extending from opposed sides of the concavecross-section and generally linearly from the concave cross-section; asecond component connected to the first component and having a non-metalmaterial composition from the first component, the second componenthaving a first surface lining an inside of the concave cross-sectionshort of the first and second flanged edge portions, and a secondsurface opposite the first surface; and a strap retainer attached to thefirst component and arranged for supporting a strap; wherein the firstcomponent forms a recess adapted for receiving the strap retainer. 2.The frame of claim 1, wherein the first component is constructed from ametal alloy.
 3. The frame of claim 2, wherein the second component isconstructed from a non-metal material.
 4. The frame of claim 1, whereinthe second component is constructed from a resin-impregnated materialincluding a plurality of reinforcement fibers.
 5. The frame of claim 4,wherein the second side follows a shape of the first side and extendsparallel therewith along a length of the first component.
 6. The frameof claim 5, wherein a thickness separates the first and second sides,and is generally uniform along the length of the first component.
 7. Theframe of claim 4, wherein the second component extends at least alongthe concave cross-section.
 8. The frame of claim 4, wherein theplurality of reinforcement fibers is selected from the group consistingof carbon, glass, and Kevlar.
 9. The frame of claim 1, wherein the firstcomponent includes a first segment extending in a first direction and asecond segment generally parallel with the first segment, a curvedsegment extending between the first and second segments and generallyperpendicular to the first direction such that the second componentextends continuously along the first component from the first and secondsegments.
 10. The frame of claim 1, further comprising a padding layerextending along the second surface of the second component and beyondthe first and second flanged edge portions so as to form edge portionsextending laterally beyond the first and second flanged edge portions.11. The frame of claim 1, wherein the strap retainer includes a wirehaving first and second ends pivotally attached to the first component,the wire being formed from an alloy or other suitable metal, polymer, orcomposite material.
 12. The frame of claim 11, wherein the strapretainer further includes a roller secured to the wire and arranged fora strap to extend thereover.
 13. The frame of claim 11, wherein therecess is defined about an exterior surface of the first component intowhich the strap retainer extends and receives the strap.
 14. The frameof claim 1, wherein the strap retainer is formed by the structuralmaterial and integrated with the first component, the strap retainerextending within the recess, the strap retainer configured anddimensioned for supporting a strap.
 15. The frame of claim 14, whereinthe strap retainer forms a bar extending from opposed sides continuouslywithin the recess of the first component, the bar being suspended overthe recess to form a clearance therewith arranged for a strap to extendtherethrough.
 16. The frame of claim 15, wherein the bar extends solelywithin the recess and is arranged not to extend outwardly beyond an edgeof a periphery of the first component.
 17. The frame of claim 16,wherein the recess defines an outlet proximate the edge of the firstcomponent, the recess having a depth transitioning and reducing to theedge and is configured and dimensioned for the strap to be secured toand extend outwardly from the first component without protruding eitherupwardly or laterally beyond the periphery of the first component.
 18. Aframe in an orthopedic device, comprising: a first component made from astructural material, the first component defining first and secondsides, the first and second sides being coextensive and parallel so asto form a concave cross-section bounded by first and second flanged edgeportions extending from opposed sides of the concave cross-section andgenerally linearly from the concave cross-section, wherein the firstcomponent is constructed from a metal alloy; a second componentconnected to the first component and having a different materialcomposition from the first component, the second component having afirst surface lining an inside of the concave cross-section short of thefirst and second flanged edge portions, and a second surface oppositethe first surface; a strap retainer attached to the first component andarranged for supporting a strap; wherein the first component forms arecess adapted for receiving the strap retainer.
 19. The frame of claim18, further comprising a padding layer extending along the secondsurface of the second component and beyond the first and second flangededge portions so as to form edge portions extending laterally beyond thefirst and second flanged edge portions.
 20. A frame in an orthopedicdevice, comprising: a first frame segment formed by a structuralmaterial, the first frame segment defining interior and exterior sidessuch that the interior side is arranged to face a limb of a user, thefirst frame segment forming a recess along the exterior side thereof; astrap retainer formed by the structural material and integrated with thefirst frame segment, the strap retainer extending within the recess, thestrap retainer configured and dimensioned for supporting a strap;wherein the strap retainer forms a bar extending from opposed sidescontinuously within the recess of the first frame segment, the bar beingsuspended over the recess to form a clearance therewith arranged for astrap to extend therethrough; wherein the bar extends solely within therecess and is arranged not to extend outwardly beyond an edge of aperiphery of the first frame segment; wherein the recess defines anoutlet proximate the edge of the first frame segment, the recess havinga depth transitioning and reducing to the edge and is configured anddimensioned for the strap to be secured to and extend outwardly from thefirst frame segment without protruding either upwardly or laterallybeyond the periphery of the frame segment.